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Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children

K

King Abdullah University Hospital

Status

Completed

Conditions

Impression Taking for Space Maintainers
TOOTH Extraction
Stainless-steel Crown
Fissure Sealant
Space Maintainer
FLUORIDE THERAPY
SCALING
Restorations
Pulp Therapy

Treatments

Device: VR-The iWear

Study type

Interventional

Funder types

Other

Identifiers

NCT06794788
Research Grant No: 20190440 (Other Grant/Funding Number)

Details and patient eligibility

About

the current study aims to assess virtual reality as an effective pain management technique for children undergoing different dental procedures.

The iWear is the immersive virtual reality device was used for this study from (Vuzix®, Rochester, New York, USA). The iWear consists of a lightweight high-end pair of video headphones that contain pair of VR goggles

Full description

The peadiatric dentist examined children to assess their needs. At the screening, a full mouth oral examination was performed. Different dental procedures needed were determined based on the outcome of the clinical examination performed. Some of these dental procedures did not require administration of local anesthesia (LA), such as fissure sealant, space maintainer, fluoride therapy, impression taking for space maintainers, and scaling. Other dental procedures require the administration of LA , such as stainless-steel crown, pulp therapy, restorations, and extraction (Figure 2). The peadiatric dentist divided the children into two groups (Group A & B) according to the need for usage of LA. The children with dental procedures not requiring administration of LA were assigned to Group A, and the children with dental procedures requiring administration of LA were assigned to Group B. A computer-generated random number was used to randomly divide the children in Group A into two sub-groups(Group A1 & A2) according to the usage of VR. Patients included in Group A1 randomly assigned to receive no VR. On the other hand, patients included in Group A2 randomly assigned to receive VR. Also, children in Group B were randomly assigned into two sub-groups (Group B1 & B2) to receive no VR or VR respectively.

Enrollment

154 patients

Sex

All

Ages

5 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children aged 5-12 years
  • Good general health,
  • Taking no medications,
  • Willingness to participate in the study

Exclusion criteria

  • Subjects with a convulsive disorder,
  • Subjects with a history of serious vestibular abnormalities,
  • Subjects with musculoskeletal disorders, or developmental delay taking psychotropic drugs

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

154 participants in 4 patient groups

GROUP A1
No Intervention group
Description:
The children with dental procedures not requiring administration of LA were assigned to Group A. Divide the children in Group A into two sub-groups(Group A1 \& A2) Patients included in Group A1 randomly assigned to receive no VR
GROUP A2
Experimental group
Description:
The children with dental procedures not requiring administration of LA were assigned to Group A. Divide the children in Group A into two sub-groups(Group A1 \& A2) Patients included in Group A2 randomly assigned to receive VR-The iWear
Treatment:
Device: VR-The iWear
GROUP B1
No Intervention group
Description:
the children with dental procedures requiring administration of LA were assigned to Group Divided the children in Group B into two sub-groups (Group B1 \& B2) Patients included in Group B1 randomly assigned to receive no VR
GROUP B2
Experimental group
Description:
the children with dental procedures requiring administration of LA were assigned to Group Divided the children in Group B into two sub-groups (Group B1 \& B2) Patients included in Group B2 randomly assigned to receive VR-The iWear
Treatment:
Device: VR-The iWear

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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